(55 days)
The Omni Foot Plaing System is internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.
The Omni Foot Plating System is a bone fixation system consisting of unalloyed Titanium plates and Titanium Alloy (Ti-6AL-4V) locking and non-locking plate screws, which meet ASTM F67 and ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by the lengths and number of holes. The plate screws are provided in diameters of 2.8mm and 3.5mm in lengths from 8mm to 50mm. The System offers 3.5mm cannulated screws in various lengths to be used as adjunctive fixation. The 3.5mm cannulated screw can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.
This document is a 510(k) premarket notification for the Omni Foot Plating System, a medical device. It does not describe an AI/ML device or present data from a study to prove a device meets acceptance criteria related to AI/ML performance. Instead, it demonstrates substantial equivalence to predicate devices through engineering analysis and materials comparison.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML system, as this document pertains to a traditional metallic bone fixation system.
Specifically:
- Table of acceptance criteria and reported device performance: Not applicable. This document is about a mechanical device, not an AI/ML system with performance metrics like sensitivity, specificity, etc.
- Sample size for test set and data provenance: Not applicable. No test set for AI/ML performance. The engineering analysis compares mechanical properties.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML (e.g., disease diagnosis) is not relevant here.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone (algorithm only) performance: Not applicable. This is a physical device, not an algorithm.
- Type of ground truth used: Not applicable for AI/ML. The "ground truth" for this device's performance would be engineering standards and material properties, confirmed by engineering analysis.
- Sample size for training set: Not applicable. There is no AI/ML model to train.
- How ground truth for training set was established: Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.